FDA Accelerates Cancer Drug Pipeline as Market Momentum Surges Past $400B September 08, 2025 - Baystreet.ca Issued on behalf of Oncolytics Biotech Inc. VANCOUVER – Baystreet.ca News Commentary – The FDA's unprecedented accelerated approval pace through August 2025 has delivered breakthrough treatments for rare brain tumors and advanced lung cancers[1], while simultaneously raising survival standards for future oncology drug approvals[2]. Major institutions are responding with massive capital deployments, as the global cancer therapy market hits $243.62 billion in 2025[3] and accelerates toward $403.99 billion by 2030. Oncology companies dominated fundraising in August, securing $505.1 million across five major rounds[4], setting the stage for other cancer players that are making big progress, including Oncolytics Biotech Inc. (NASDAQ: ONCY), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), ALX Oncology Holdings Inc. (NASDAQ: ALXO), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), and BioNTech SE (NASDAQ: BNTX). Industry analysts at Mordor Intelligence project immunotherapy revenues rising from $58 billion to $120 billion by 2030[5], while cell and gene therapy investments jumped 30% in 2024 to $15.2 billion. North American healthcare systems lead adoption of precision medicine approaches and AI-driven drug discovery platforms[6], creating favorable conditions for companies with breakthrough immunotherapies and targeted treatment platforms. Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced impressive clinical data in metastatic colorectal cancer that could accelerate the company's path to registration. The latest results show pelareorep achieved a median progression-free survival of 16.6 months compared to just 5.7 months with standard treatments, representing approximately 2.5 times longer disease control in KRAS mutant colorectal cancer patients. Even more striking, overall survival reached 27.0 months versus the typical 11.2 months, representing a dramatic improvement in one of oncology's most challenging areas. This data comes from the REO 022 trial testing pelareorep with FOLFIRI and bevacizumab in second-line treatment. "These studies validate pelareorep's mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics. “Given pelareorep’s activity in this difficult-to-treat cancer and other RAS-mutated gastrointestinal (“GI”) tumors, including metastatic pancreatic and anal cancers, we believe pelareorep is positioned to become the premier platform immunotherapy in the GI space.” The company plans to work with regulators to define a path toward registration in KRAS mutant colorectal cancer. The results extend beyond survival numbers. Translational studies confirmed pelareorep actually replicates inside tumor cells while activating immune responses, including dendritic cell maturation and CD8+ T cell activation. This proves the drug's ability to transform "cold" tumors into "hot" targets responsive to immunotherapeutic treatments. Pelareorep represents a systemically delivered oncolytic virus that reprograms the immune system against cancer. Unlike traditional chemotherapy that attacks cells indiscriminately, this immunotherapy selectively targets cancer while mobilizing the body's natural defenses. The company is simultaneously advancing toward registration-enabling trials in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), where survival data proved equally compelling. Clinical results showed a 21.9% two-year overall survival rate compared to the 9.2% historical benchmark for standard chemotherapy protocols. Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This matters because checkpoint inhibitors currently lack approval for pancreatic cancer, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumors. Oncolytics recently provided updated safety data for pelareorep, which has been administered to over 1,200 patients across multiple studies. The most common side effects remain mild flu-like symptoms, with data showing pelareorep doesn't modify the safety profile of established chemotherapy regimens. The company confirmed ongoing discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters for pancreatic cancer, targeting potential trial initiation activities by Q4 2025. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes. Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Oncolytics eliminated its At-the-Market and Equity Line financing facilities, suggesting confidence in current cash resources to reach key development milestones. With survival benefits approaching 3× standard care in colorectal cancer and regulatory discussions advancing for pancreatic cancer trials by Q4 2025, Oncolytics appears positioned at a critical inflection point where proof-of-concept has evolved into potential registration-enabling studies. The company's dual-track approach in gastrointestinal cancers, combined with an experienced leadership team and FDA Fast Track designation, suggests pelareorep may soon transition from clinical promise to commercial reality. CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include: Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) has announced a new clinical trial agreement with Pfizer Inc. to evaluate palazestrant plus atirmociclib in approximately 35 patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. Under the terms of the agreement, Pfizer will supply atirmociclib for use in the Phase 1b/2 study while Olema will lead the conduct of the study, with all clinical data and inventions relating to the combined use jointly owned. This represents Olema's second clinical trial agreement with Pfizer, following their previous November 2020 agreement to evaluate palazestrant in combination with palbociclib. "We are excited to assess this combination in the clinic as we seek to establish palazestrant as a potential backbone endocrine therapy for metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., CEO of Olema Oncology. "Based on the promising profiles of palazestrant and atirmociclib to date, we look forward to evaluating the potential of this novel combination and, if successful, advancing to a pivotal trial in the frontline setting." The study is anticipated to initiate in the second half of 2025 and will inform a potential pivotal Phase 3 trial of the novel combination in the frontline metastatic breast cancer setting. Olema maintains full global commercial and marketing rights to palazestrant, which has FDA Fast Track designation and is currently being evaluated in the ongoing pivotal Phase 3 OPERA-01 trial as a single agent. ALX Oncology Holdings Inc. (NASDAQ: ALXO) has dosed the first patient in its Phase 1 clinical trial for ALX2004, a potential best- and first-in-class epidermal growth factor receptor ADC for the treatment of EGFR-expressing solid tumors. The first-in-human trial (NCT07085091) is an open-label multicenter study that will enroll patients with previously treated advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma and colorectal cancer. ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window, including an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies and a proprietary topoisomerase I inhibitor payload engineered for enhanced bystander effect. "Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology's mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs," said Jason Lettmann, CEO of ALX Oncology. "Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs." Initial safety data is anticipated in the first half of 2026, with preclinical studies demonstrating dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a differentiated safety profile compared to earlier generation EGFR-targeted ADCs. Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) has received Health Canada approval for Amtagvi (lifileucel), marking the first T cell therapy approved for a solid tumor cancer and first treatment option approved in Canada for advanced melanoma after anti-PD-1 and targeted therapy. Health Canada issued a Notice of Compliance with Conditions for the tumor-derived autologous T cell immunotherapy, indicated for adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy, including a PD-1 blocking antibody. The market authorization was granted based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy where applicable. "This approval in Canada is our first marketing authorization outside the U.S. and marks a significant step forward for Iovance as we prepare to introduce Amtagvi in countries with a high prevalence of advanced melanoma and address substantial unmet needs in solid tumor cancers," said Frederick Vogt, Ph.D., J.D., Interim CEO and President of Iovance. "We expect to authorize our first Canadian treatment center within the next few months, and we continue to advance our ex-U.S. strategy for Amtagvi in additional markets." Iovance is investigating Amtagvi in frontline advanced melanoma in the Phase 3 trial TILVANCE-301, as well as in additional solid tumor types. The company aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte therapies for patients with cancer, with Amtagvi representing the first FDA-approved T cell therapy for a solid tumor indication. BioNTech SE (NASDAQ: BNTX) has announced positive Phase 3 results for trastuzumab pamirtecan (BNT323/DB-1303), with the investigational next-generation antibody drug-conjugate targeting HER-2 meeting its primary endpoint of progression-free survival in an interim analysis conducted in China. The pivotal Phase 3 trial enrolled 228 patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy, comparing trastuzumab pamirtecan to the approved ADC trastuzumab emtansine (T-DM1). Based on the positive interim analysis results shared by the Independent Data Monitoring Committee, DualityBio plans to discuss next steps with China's National Medical Products Administration regarding submission of a Biologics License Application. "This is a milestone in the fruitful collaboration with our colleagues at DualityBio," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. "We believe that trastuzumab pamirtecan is an ADC candidate with enormous potential which makes it an important asset in our global oncology strategy including combinational approaches. It is the first of our late-stage oncology programs to meet its primary endpoint in a pivotal Phase 3 trial and also highlights our commitment to bringing novel oncology treatments with distinct profiles to patients." This marks the first positive Phase 3 data readout achieved in BioNTech's and DualityBio's strategic collaboration initiated in April 2023, with BioNTech holding global commercial rights excluding Mainland China, Hong Kong and Macau. The companies are also conducting a global Phase 3 DYNASTY-Breast02 trial evaluating trastuzumab pamirtecan in HR-positive, HER2-low metastatic breast cancer, with the BNT323/DB-1303 program having received FDA Fast Track and Breakthrough Therapy designations for endometrial cancer treatment. Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT: Baystreet.ca [email protected] (250) 999-4849 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Baystreet.ca is a wholly-owned subsidiary of Baystreet.ca Media Corp. (“BAY”) BAY has been not been paid a fee for Oncolytics Biotech Inc. advertising and/or digital media, but the owner(s) of BAY also own Market IQ Media Group, Inc., which has been paid a fee from the company directly. There may be 3rd parties who may have shares Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of BAY own shares of Oncolytics Biotech Inc. which were purchased in the open market. BAY and all of it’s respective employees, owners and affiliates reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by BAY has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. 1. https://www.targetedonc.com/view/a-month-of-breakthroughs-the-fda-s-oncology-decisions-in-august-2025 2. https://www.biospace.com/fda/fda-looks-to-raise-survival-bar-for-cancer-drug-approvals-in-new-draft-guidance 3. https://www.mordorintelligence.com/industry-reports/cancer-therapy-market 4. https://www.labiotech.eu/in-depth/biotech-funding-rounds-august-2025/ 5. https://www.mordorintelligence.com/industry-reports/cancer-therapy-market 6. https://www.pharmiweb.com/press-release/2025-08-28/the-oncology-market-is-experiencing-explosive-growth
FDA Accelerates Cancer Drug Pipeline as Market Momentum Surges Past $400B September 08, 2025 - Baystreet.ca Issued on behalf of Oncolytics Biotech Inc. VANCOUVER – Baystreet.ca News Commentary – The FDA's unprecedented accelerated approval pace through August 2025 has delivered breakthrough treatments for rare brain tumors and advanced lung cancers[1], while simultaneously raising survival standards for future oncology drug approvals[2]. Major institutions are responding with massive capital deployments, as the global cancer therapy market hits $243.62 billion in 2025[3] and accelerates toward $403.99 billion by 2030. Oncology companies dominated fundraising in August, securing $505.1 million across five major rounds[4], setting the stage for other cancer players that are making big progress, including Oncolytics Biotech Inc. (NASDAQ: ONCY), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), ALX Oncology Holdings Inc. (NASDAQ: ALXO), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), and BioNTech SE (NASDAQ: BNTX). Industry analysts at Mordor Intelligence project immunotherapy revenues rising from $58 billion to $120 billion by 2030[5], while cell and gene therapy investments jumped 30% in 2024 to $15.2 billion. North American healthcare systems lead adoption of precision medicine approaches and AI-driven drug discovery platforms[6], creating favorable conditions for companies with breakthrough immunotherapies and targeted treatment platforms. Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced impressive clinical data in metastatic colorectal cancer that could accelerate the company's path to registration. The latest results show pelareorep achieved a median progression-free survival of 16.6 months compared to just 5.7 months with standard treatments, representing approximately 2.5 times longer disease control in KRAS mutant colorectal cancer patients. Even more striking, overall survival reached 27.0 months versus the typical 11.2 months, representing a dramatic improvement in one of oncology's most challenging areas. This data comes from the REO 022 trial testing pelareorep with FOLFIRI and bevacizumab in second-line treatment. "These studies validate pelareorep's mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics. “Given pelareorep’s activity in this difficult-to-treat cancer and other RAS-mutated gastrointestinal (“GI”) tumors, including metastatic pancreatic and anal cancers, we believe pelareorep is positioned to become the premier platform immunotherapy in the GI space.” The company plans to work with regulators to define a path toward registration in KRAS mutant colorectal cancer. The results extend beyond survival numbers. Translational studies confirmed pelareorep actually replicates inside tumor cells while activating immune responses, including dendritic cell maturation and CD8+ T cell activation. This proves the drug's ability to transform "cold" tumors into "hot" targets responsive to immunotherapeutic treatments. Pelareorep represents a systemically delivered oncolytic virus that reprograms the immune system against cancer. Unlike traditional chemotherapy that attacks cells indiscriminately, this immunotherapy selectively targets cancer while mobilizing the body's natural defenses. The company is simultaneously advancing toward registration-enabling trials in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), where survival data proved equally compelling. Clinical results showed a 21.9% two-year overall survival rate compared to the 9.2% historical benchmark for standard chemotherapy protocols. Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This matters because checkpoint inhibitors currently lack approval for pancreatic cancer, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumors. Oncolytics recently provided updated safety data for pelareorep, which has been administered to over 1,200 patients across multiple studies. The most common side effects remain mild flu-like symptoms, with data showing pelareorep doesn't modify the safety profile of established chemotherapy regimens. The company confirmed ongoing discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters for pancreatic cancer, targeting potential trial initiation activities by Q4 2025. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes. Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Oncolytics eliminated its At-the-Market and Equity Line financing facilities, suggesting confidence in current cash resources to reach key development milestones. With survival benefits approaching 3× standard care in colorectal cancer and regulatory discussions advancing for pancreatic cancer trials by Q4 2025, Oncolytics appears positioned at a critical inflection point where proof-of-concept has evolved into potential registration-enabling studies. The company's dual-track approach in gastrointestinal cancers, combined with an experienced leadership team and FDA Fast Track designation, suggests pelareorep may soon transition from clinical promise to commercial reality. CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include: Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) has announced a new clinical trial agreement with Pfizer Inc. to evaluate palazestrant plus atirmociclib in approximately 35 patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. Under the terms of the agreement, Pfizer will supply atirmociclib for use in the Phase 1b/2 study while Olema will lead the conduct of the study, with all clinical data and inventions relating to the combined use jointly owned. This represents Olema's second clinical trial agreement with Pfizer, following their previous November 2020 agreement to evaluate palazestrant in combination with palbociclib. "We are excited to assess this combination in the clinic as we seek to establish palazestrant as a potential backbone endocrine therapy for metastatic breast cancer," said Sean P. Bohen, M.D., Ph.D., CEO of Olema Oncology. "Based on the promising profiles of palazestrant and atirmociclib to date, we look forward to evaluating the potential of this novel combination and, if successful, advancing to a pivotal trial in the frontline setting." The study is anticipated to initiate in the second half of 2025 and will inform a potential pivotal Phase 3 trial of the novel combination in the frontline metastatic breast cancer setting. Olema maintains full global commercial and marketing rights to palazestrant, which has FDA Fast Track designation and is currently being evaluated in the ongoing pivotal Phase 3 OPERA-01 trial as a single agent. ALX Oncology Holdings Inc. (NASDAQ: ALXO) has dosed the first patient in its Phase 1 clinical trial for ALX2004, a potential best- and first-in-class epidermal growth factor receptor ADC for the treatment of EGFR-expressing solid tumors. The first-in-human trial (NCT07085091) is an open-label multicenter study that will enroll patients with previously treated advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma and colorectal cancer. ALX2004 is uniquely designed with every component optimized to maximize the therapeutic window, including an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies and a proprietary topoisomerase I inhibitor payload engineered for enhanced bystander effect. "Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology's mission to develop a pipeline of best-in-class drugs; ALX2004 is our first ADC and treating our first patient with this drug is a significant step forward in fulfilling the potential of EGFR-targeted ADCs," said Jason Lettmann, CEO of ALX Oncology. "Our preclinical data supports our conviction that ALX2004, with its optimized antibody, linker and payload, has the potential to overcome the toxicity challenges that have limited earlier generation EGFR-targeted ADCs." Initial safety data is anticipated in the first half of 2026, with preclinical studies demonstrating dose-dependent activity across a range of tumors, EGFR expression levels and mutations. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, supportive of a differentiated safety profile compared to earlier generation EGFR-targeted ADCs. Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) has received Health Canada approval for Amtagvi (lifileucel), marking the first T cell therapy approved for a solid tumor cancer and first treatment option approved in Canada for advanced melanoma after anti-PD-1 and targeted therapy. Health Canada issued a Notice of Compliance with Conditions for the tumor-derived autologous T cell immunotherapy, indicated for adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy, including a PD-1 blocking antibody. The market authorization was granted based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy where applicable. "This approval in Canada is our first marketing authorization outside the U.S. and marks a significant step forward for Iovance as we prepare to introduce Amtagvi in countries with a high prevalence of advanced melanoma and address substantial unmet needs in solid tumor cancers," said Frederick Vogt, Ph.D., J.D., Interim CEO and President of Iovance. "We expect to authorize our first Canadian treatment center within the next few months, and we continue to advance our ex-U.S. strategy for Amtagvi in additional markets." Iovance is investigating Amtagvi in frontline advanced melanoma in the Phase 3 trial TILVANCE-301, as well as in additional solid tumor types. The company aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte therapies for patients with cancer, with Amtagvi representing the first FDA-approved T cell therapy for a solid tumor indication. BioNTech SE (NASDAQ: BNTX) has announced positive Phase 3 results for trastuzumab pamirtecan (BNT323/DB-1303), with the investigational next-generation antibody drug-conjugate targeting HER-2 meeting its primary endpoint of progression-free survival in an interim analysis conducted in China. The pivotal Phase 3 trial enrolled 228 patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy, comparing trastuzumab pamirtecan to the approved ADC trastuzumab emtansine (T-DM1). Based on the positive interim analysis results shared by the Independent Data Monitoring Committee, DualityBio plans to discuss next steps with China's National Medical Products Administration regarding submission of a Biologics License Application. "This is a milestone in the fruitful collaboration with our colleagues at DualityBio," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. "We believe that trastuzumab pamirtecan is an ADC candidate with enormous potential which makes it an important asset in our global oncology strategy including combinational approaches. It is the first of our late-stage oncology programs to meet its primary endpoint in a pivotal Phase 3 trial and also highlights our commitment to bringing novel oncology treatments with distinct profiles to patients." This marks the first positive Phase 3 data readout achieved in BioNTech's and DualityBio's strategic collaboration initiated in April 2023, with BioNTech holding global commercial rights excluding Mainland China, Hong Kong and Macau. The companies are also conducting a global Phase 3 DYNASTY-Breast02 trial evaluating trastuzumab pamirtecan in HR-positive, HER2-low metastatic breast cancer, with the BNT323/DB-1303 program having received FDA Fast Track and Breakthrough Therapy designations for endometrial cancer treatment. Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT: Baystreet.ca [email protected] (250) 999-4849 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Baystreet.ca is a wholly-owned subsidiary of Baystreet.ca Media Corp. (“BAY”) BAY has been not been paid a fee for Oncolytics Biotech Inc. advertising and/or digital media, but the owner(s) of BAY also own Market IQ Media Group, Inc., which has been paid a fee from the company directly. There may be 3rd parties who may have shares Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of BAY own shares of Oncolytics Biotech Inc. which were purchased in the open market. BAY and all of it’s respective employees, owners and affiliates reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by BAY has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. 1. https://www.targetedonc.com/view/a-month-of-breakthroughs-the-fda-s-oncology-decisions-in-august-2025 2. https://www.biospace.com/fda/fda-looks-to-raise-survival-bar-for-cancer-drug-approvals-in-new-draft-guidance 3. https://www.mordorintelligence.com/industry-reports/cancer-therapy-market 4. https://www.labiotech.eu/in-depth/biotech-funding-rounds-august-2025/ 5. https://www.mordorintelligence.com/industry-reports/cancer-therapy-market 6. https://www.pharmiweb.com/press-release/2025-08-28/the-oncology-market-is-experiencing-explosive-growth